Clearance Summary
MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL received FDA 510(k) clearance under submission number K241053, sponsored by Medtronic Cardiac Surgery. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-05-15.
- Submission: K241053
- Applicant / Sponsor: Medtronic Cardiac Surgery
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 2024-05-15
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.